The Interventional Perspective: Long Term Data on Carotid Stenting

Supports Its Efficacy In Stroke Prevention

Emerging And Novel Insights From CaRESS, SAPPHIRE. ARCHeR And Others

Subbarao Myla MD, FACC, FSCAIHoag Memorial Hospital Presbyterian

Newport Beach, CA, USA

Disclosures

• Research Grant Support: Johnson & Johnson, Boston Scientific, Endotex, eV3, CR

Bard, Abbott, Lumen Bio

• Consultant, Scientific Advisory Board member Johnson & Johnson, Boston Scientific, Lumen Bio

• Stockholder Boston Scientific, Lumen Bio

Objectives

• Is CAS Durable? In Stroke Prevention?

• Compared to what? CEA or Medical RX• In which patient groups?

In Maintaining Patency?• Restenosis• Role in stroke• Issues With Carotid Duplex

Historical, Randomized And Registry Trials

• Medical Therapy• NASCET. ACAS. • ECST. ACST• CAVATAS• SAPPHIRE, ARCHER. CaRESS• SPACE, EVA 3S• CREST lead In

No Comparator For Medical Therapy In High Risk Patients

Successful Technology Transfer with improving Learning Curve

Long Term Stroke Risk

SPACE

3.9

9.6

0

5

10

15

20

Primary Endpoint

30 d

ay d

eath

and

str

oke

(%)

CEA CAS

EVA-3S: Randomized CEA vs. CAS

RR 2.5 (95% CI, 1.2-5.1) P=0.01

262262 265265

Mas JL et al. New Engl J Med 2006;355:1661-71Mas JL et al. New Engl J Med 2006;355:1661-71

EVA 3S Study

Mas JL et al, Lancet September 2008Mas JL et al, Lancet September 2008

CARESS STUDY

• No difference in Any Stroke between Surgery or stent at 30 days or 4 yrs.

• Interval CEA Stent P• 30 days 2.2% 2.0% NS• 4 yrs 9.6% 8.6% NS

JVS2005, C.Zarins TCT 2009 Oct 11th 2008

CREST RESTENOSIS

Helmut Lutsup for CREST Investigators 2007

Helmut Lutsup for CREST Investigators 2007

CREST RESTENOSIS

CREST RESTENOSIS

Helmut Lutsup for CREST Investigators 2007

CARESS RESTENOSIS

• Baseline characteristics Impacting Restenosis.

• Restenosis as Inclusion Criteria CEA 11%CAS 36% P < 0.001

JVS2005, C.Zarins TCT 2009 Oct 11th 2008

• 4 yr Restenosis by Duplex/ Angiography • Procedure CEA CAS P

Restenosis 5.9% 14.7% 0.01 Repeat Angio 5.1% 11.2% 0.05 TVR 2.18% 5.6% 0.26

• Hawthorne Effect• More angiography triggers more TVR• Duplex Criteria?

JVS2005, C. Zarins TCT 2009 Oct 11th 2008

CARESS RESTENOSIS

• Restenosis by Duplex/ Angiography • Procedure I yr 4 yr

CEA 3.6% 5.9%CAS 6.3% 14.7%

P < 0.001

JVS2005, C. Zarins TCT 2009 Oct 11th 2008

CARESS RESTENOSIS

Is Restenosis Stent Dependent?

New Criteria PSV >217cm/s or ICA/CCA Ratio >2.98 Predicts >50% Stenosis

Conclusions

• CAS is a durable procedure in Stroke Prevention and maintaining Patency

• CAS Restenosis is a benign uncommon event.

• Carotid Duplex Criteria for CAS follow up need validation